JP7059352B2 - Automatic fluid injection device - Google Patents

Description

The present invention relates to an automatic fluid injection device.

Automatic fluid infusion devices are a known technique and include, in particular, self-injectors. In a self-injector, the fluid contained in a container, typically a syringe, is automatically injected by the actuator system. This actuator system typically includes a load spring, which, when activated, causes the piston to move inside the container to inject fluid.

Problems can arise with such conventional equipment. Specifically, there are cases where the administration fluid is large or relatively viscous, or it is necessary to combine a plurality of types of fluids and administer them at one time.

Patent Documents 1 to 4 disclose conventional devices.

International Publication No. WO2008 / 024814 International Publication No. WO2004 / 056411 European Patent Application Publication No. 0462508 U.S. Patent Application Publication No. 2010/0213111

An object of the present invention is to provide an automatic fluid injection device that does not cause the above-mentioned problems.

Another object of the present invention is to provide an automatic fluid injection device capable of automatic injection even if the fluid is large and / or highly viscous.

Yet another object of the present invention is to provide an inexpensive automatic fluid injection device that is easy to manufacture and assemble.

Therefore, the present invention is an automatic fluid injection device, which is a needle assembly including a main body fixed to a support for contacting an injection site, an injection needle for piercing the injection site, and a puncture actuator composed of a shape memory alloy. And an automatic fluid injection device including an injection mechanism. The body comprises one or more containers containing the fluid. The container has an injection piston inside. The injection mechanism includes a retractable ring, a needle support portion, a puncture ring to which one end of the puncture actuator is fixed, an retractable spring, an actuator ring, and a puncture spring. The puncture spring and the retract spring are held in a compressed state by the corresponding blocking means at the time of rest. When the puncture actuator is operated by heating until its contraction reaches 50% of the maximum contraction, the actuator ring moves with respect to the puncture ring, so that the needle support portion is released and the puncture spring is released. Extend and insert the needle into the injection site. When the puncture actuator is heated by heating until its contraction reaches 100% of the maximum contraction, the actuator ring moves relative to the retract ring to cause the puncture ring, the needle support and the injection. The retractable spring retracts the needle from the injection site as the needle is released from the interconnected assembly.

Advantageously, the puncture actuator is a wire, preferably a wire made of a nickel-titanium alloy (Nitinol).

Advantageously, the wire transforms into a martensite phase upon heating, changing its physical dimensions, specifically its length.

Advantageously, the injection mechanism heats and inflates an actuator cap containing an inflatable material and the inflatable material to move the injection piston inside the container, thereby causing the fluid from the injection needle. Includes a heating means for injecting the injection site.

Advantageously, the inflatable material comprises thermally inflatable microspheres.

Advantageously, the thermally expandable microspheres include hollow thermoplastic microspheres encapsulated with hydrocarbons.

Advantageously, the thermoplastic microspheres are heated to a temperature range of 60 ° C. to 90 ° C. and expand to transform into a gas phase, so that the thermally expandable microspheres are 5 to 70 times the original volume. Inflate.

Advantageously, the support has a sticker for fixing to the injection site.

Advantageously, the amount of fluid contained in each of the containers ranges from 1 milliliter (mL) to 10 mL, preferably about 3 mL.

Advantageously, the number of the containers is a plurality, preferably three.

Advantageously, the automatic fluid injection device further comprises a power source means, preferably any rechargeable battery.

The detailed description and accompanying drawings shown below clarify the features and advantages of the present invention based on non-limiting examples.
It is an exploded perspective view which shows the automatic fluid injection apparatus which concerns on a preferable embodiment. It is a side view which shows the apparatus of FIG. 1 before priming. It is a side view which shows the apparatus of FIG. 1 after priming. It is an exploded perspective view of the needle assembly which concerns on a preferred embodiment. It is a side view which shows the operation sequence of the needle assembly of FIG. It is a side view which shows the operation sequence of the needle assembly of FIG. It is a side view which shows the operation sequence of the needle assembly of FIG. It is a side view which shows the operation sequence of the needle assembly of FIG. It is a side view which shows the operation sequence of the apparatus of FIG. It is a side view which shows the operation sequence of the apparatus of FIG. It is a side view which shows the operation sequence of the apparatus of FIG. It is a figure explaining the operation of the microsphere which sealed the hydrocarbon. It is a graph which shows the volume expansion of the microsphere containing a hydrocarbon as a function of temperature.

The present invention relates to an automatic fluid infusion device particularly suitable for administration of relatively large amounts of fluid. The dosing fluid is about several mL, typically in the range of 1 mL to 10 mL, for example 3 mL. The automatic fluid injection device of the present invention is also suitable for administration of a relatively viscous fluid.

The device of the present invention is preferably disposable and can be operated by the following procedure.

1) Remove the device from the packaging and fix it to the injection site, for example, with a special sticker.

2) Press the actuator button 200 to operate the device. Specifically, priming, insertion of the injection needle into the injection site, administration of fluid, and withdrawal of the injection needle are performed.

3) When the injection procedure is completed, you will be notified to that effect, so dispose of the device away from your body.

FIG. 1 shows an automatic fluid injection device according to a preferred embodiment.

The apparatus includes a main body 1, a priming assembly 3, a needle assembly 4, injection mechanisms 7 to 11, and power supply means (not shown). The body 1 is secured to a support 2 for contact with the injection site and includes one or more containers 5 containing a fluid. The container 5 has an injection piston 6 inside. The priming assembly 3 includes a priming actuator and one or more priming needles 31 for piercing the container 5. The needle assembly 4 includes an injection needle 40 (not shown in FIG. 1) for piercing the injection site.

As an example, the power supply means may be any rechargeable battery.

The injection mechanism according to this embodiment is a thermal type.

In the system according to the present embodiment, the priming assembly 3 and the needle assembly 4 are combined with the three containers 5.

Activating the device results in a series of internal control processes as described below.

1) The priming assembly 3 is activated to notify the priming controller that the piercing into the membrane or container is complete. The priming assembly 3 may include a notification mechanism such as a micro switch.

2) The injection needle is inserted by an electronically controlled mechanism. The system may also include a notification unit that notifies the injection controller of the completion of the puncture.

3) The injection mechanism operates.

4) The injection needle is retracted by an electronically controlled mechanism. Notification mechanisms such as microswitches and open-loop timers notify the user that the device may be removed from the body, eg visually using a diode and / or audibly using an audio signal.

In the above sequence, the priming assembly and injection assembly, specifically the priming needle and injection needle, may contain a small amount of air. When the device is used in such a state, the fluid is injected into the subcutaneous tissue while the needle contains air.

If even trace amounts of air content are unacceptable, the device operating sequence may include the following additional step 1.1.

1.1) Between the completion of priming and the insertion of the needle into the injection site, activate the injection mechanism early to expel a small amount of fluid from the container to deflate the priming assembly and injection assembly. ..

Advantageously, as can be seen from FIGS. 2 and 3, the container 5 is closed with a membrane body 35 made of a septum until the operation is started, and when the operation is started, the priming needle 31 corresponding to each container is pierced.

The priming assembly 3 preferably moves on a single axis of motion controlled by a linear priming actuator (not shown).

As the priming actuator, an appropriate type can be considered. Specifically, it is a shape memory alloy (SMA) actuator, an electromagnetic solenoid type actuator, and an electromagnetic worm gear type actuator.

When the device is activated, the priming assembly 3 performs the following operations.

1) The priming needle 31 is closed with, for example, a mask 32 made of an elastomer until the start of operation during rest, so that the sterilized state is maintained.

2) When the priming actuator is activated, the priming assembly 3 advances toward the membrane 35 of the container 5, as indicated by the arrow F in FIG.

3) Since the needle mask 32 is pressed against the container 5 and deformed, the priming needle 31 continuously advances through the membrane body 35 and pierces the container 5.

4) The priming actuator keeps the priming needle 31 in place while the drug is properly administered.

The advantages obtained by the above embodiments are described in detail below.

1) The priming needle 31 is protected in a sterile environment during rest.

2) The priming assembly 3 works if there is at least one container 5. Thus, if any of the priming needles 31 remain unused or do not pierce the container, the system will not work for such needles, but for the rest of the needles. ..

When priming is complete, the puncture actuator inserts the needle 40 of the needle assembly 4 into the patient's injection site.

When a plurality of containers 5 are used as illustrated in FIGS. 1 to 3, the priming needles 31 that pierce each of the containers 5 are connected to a single injection needle 40.

Advantageously, the needle assembly 4, in addition to the injection needle 40, has an arbitrary needle sleeve 41, a retract ring 42, a needle support 44, a puncture ring 45, a retract spring 46, an actuator ring 47, and a puncture. It includes a spring 48 and a puncture actuator made of a shape memory alloy (SMA). In this embodiment, the puncture actuator is a wire 49.

SMA materials such as nickel-titanium alloys (Nitinol) transform into a martensite phase upon heating. Advantageously, the Joule effect can be utilized for this heating. When the SMA material undergoes a phase transformation, its physical dimensions change. In other words, the length of the wire 49 according to this embodiment shrinks.

The maximum strain that can occur with SMA wires is generally about 10%. Advantageously, in this embodiment, the loop causes the components to take the necessary movements.

When cooled, the SMA wire 49 returns to its original physical state by natural convection after the activation current is cut off in this embodiment. Here, the spring element for the wire to return to its initial shape is a series of curved tabs 470 built into the actuator ring 47.

Both the puncture spring 48 and the retract spring 46 for the needle are in a compressed state and are held by the corresponding blocking means.

When the SMA actuator 49 is actuated by Joule heating until its contraction reaches 50% of the maximum contraction, the actuator ring 47 moves towards the shoulder portion 451 of the puncture ring 45. One end of the SMA actuator 49 is fixed to the shoulder portion 451.

In the illustrated embodiment, this movement deforms the snap fastening tab 440 of the needle support portion 44, releases the needle support portion 44, and extends the puncture spring 48.

When the puncture spring 48 is extended, the needle support 44 and the injection needle 40 pass through the central hole of the puncture ring 45.

The extension of the puncture spring 48 causes the injection needle 40 to be inserted into the patient's injection site.

In the illustrated embodiment, the snap fastening tab 440 engages with the notch 450 provided in the main body of the puncture ring 45, and the movement of the needle support portion 44 is stopped.

FIG. 7 shows the puncture mechanism with the needle inserted.

The cross-sectional view of FIG. 7 is rotated 45 ° with respect to FIG. 6 to show the function of the snap fastening tab 420 of the retract ring 42.

When the SMA actuator 49 (not shown in FIG. 7) is actuated by Joule heating until its contraction reaches 100% of its maximum contraction, the actuator ring 47 moves towards the snap-on tab 420 of the retract ring 42. ..

In the illustrated embodiment, this movement deforms the snap fastening tab 420 of the retracting ring 42 to release the puncture ring 45.

The snap fastening tab 420 is released and the retracting spring 46 expands to activate the puncture ring 45 and the assembly in which the needle support 44 and the injection needle 40 are interconnected.

By this operation, the injection needle 40 is retracted from the user's body.

Advantageously, once the actuator wire 49 has stopped working, the mechanism remains in place.

Once the needle has been inserted, the injection mechanism is activated.

The injection mechanism according to the illustrated embodiment includes an actuator cap 7 containing an inflatable material, an actuator body 8, and a heating means 9. Specifically, the heating means 9 is a wire utilizing the Joule effect, and is wound around the reel 10.

The injection mechanism according to the illustrated embodiment further comprises a device 11 such as an optical encoder for measuring the displacement angle of the reel 10.

The main power of fluid administration is the pressure generated in the container 5 by the volume expansion of the material of the actuator cap 7.

The operation mode can be explained as follows.

1) During hibernation, the actuator cap 7 is held by the actuator main body 8 fixed to the edge of the container 5. The actuator body 8 supports two reels 10 and an encoder 11 around which the heating wire 9 is partially wound. The heating wire 9 extends into the actuator main body 8 through the actuator cap 7 and is fixed to the piston 6 of the container 5.

2) The heating wire 9 is heated by supplying an electric current. The heating wires 9 are arranged at sufficient intervals so that the internal temperature of the actuator is generally uniform in the range of 60 ° C to 90 ° C. When the internal temperature of the actuator reaches this range, the volume of the material of the actuator cap 7 expands significantly.

3) Due to the volume expansion of the material of the actuator cap 7, the piston 6 moves along the length of the container 5. The heating wire 9, which can be sent out from the rotatable reel 10, is tensioned by the movement of the piston 6. Further, by this mechanism, the entire expanded portion of the actuator cap 7 including the inflatable material is continuously heated, so that the expansion of the actuator cap 7 can be maintained.

4) The internal temperature of the actuator and its associated expansion are regulated by controlling the supply current. This adjustment is determined by monitoring the movement of the piston 6 measured by the encoder 11. When sufficient fluid is administered from the vessel 5, the supply current is cut off and the procedure ends.

One means of expanding the volume of the actuator cap 7 by thermal stimulation is the use of thermally expandable microspheres. The thermally expandable microsphere is a hollow thermoplastic microsphere (diameter about 12 micrometers (μm)) in which a hydrocarbon is encapsulated.

The encapsulated liquid is a saturated hydrocarbon, which is heated to a temperature range of 60 ° C to 90 ° C, expands, and transforms into a gas phase. The encapsulation medium is a thermoplastic substance that softens by the action of heating, and the thermoplastic microspheres are thermally expanded to 5 to 70 times the original volume (Y. Nishiyama, U. Nobuyuki and C. Sato, "heat". Degradation Behavior and Strength of Decomposable Adhesives Containing Expandable Particles ”, Int. J. Attachment & Adhesives, 2003, Vol. 23, 5th Print, p. 377-382). Here, since the total volume expands 9 times under an external pressure of 1 megapascal (MPa), the piston 6 moves 45 mm from the actuator cap 7 having an original length of 5 mm.

Heating is stopped at the end of the actuator stroke. The coefficient of the hydrocarbon-encapsulated thermoplastic material is increased so that the contraction of the expanded microspheres can be prevented. This means that the stroke of the actuator cannot be reused.

Hydrocarbon-encapsulated microspheres are available as fillers from suppliers such as AkzoNobel (Sweden) and Matsumoto Yushi Pharmaceutical Co., Ltd. (Japan).

FIG. 13 shows a graph of the volume expansion ratio measured by changing the external pressure for the microspheres containing hydrocarbons (Source: Nishiyama et al., 2003).

FIG. 12 shows a description of microspheres available from the AkzoNobel Expansel® series (Source: AkzoNobel, Expancel® Microspheres Introduction).

When the injection procedure is completed, the puncture actuator 8 retracts the injection needle into the device. For example, when the drive mechanism 7 is fully expanded, the end of the procedure can be confirmed by machine monitoring and / or software monitoring.

The apparatus according to the embodiment shown in FIG. 1 includes three containers 5. The three drive mechanisms 7 can operate simultaneously to simultaneously administer fluid from the corresponding container 5. In this way, the fluids of each of the containers 5 are mixed upstream of the injection needle 40. As a modification, the three drive mechanisms 7 may operate continuously to continuously administer the fluid from the corresponding container 5. Further, the continuous operation may be performed independently, or the administration sequence may be automatically performed by a single operation. It is also possible to combine these two variants. For example, administration is performed in two steps. Specifically, the fluid in one container is first administered, and then the fluids in the remaining two containers are mixed and administered at the same time.

The advantages gained by including multiple containers in the device are detailed below.

Two or more fluids can be administered in a single device, even in different amounts.

Being able to administer two or more fluids in combination or in combination.

The fluid can be administered in combination with analgesics (anesthetics, acid neutralizers, etc.).

The development cost of the equipment can be reduced.

Being able to adjust the fluid formulation.

The ability to accommodate various fluids in a single device.

The number of injections can be reduced.

Although the present invention has been described based on preferred embodiments, those skilled in the art will of course be able to apply any modification as long as it does not deviate from the scope of the invention as defined in the appended claims.

Claims (11)

It is an automatic fluid injection device,
The main body (1) fixed to the support (2) for contact with the injection site,
A needle assembly (4) including an injection needle (40) for puncturing the injection site and a puncture actuator (49) made of a shape memory alloy.
Equipped with an injection mechanism (7,8,9,10,11)
The body (1) comprises one or more containers (5) containing a fluid.
The container (5) has an injection piston (6) inside the container (5).
The needle assembly (4) is
With the evacuation ring (42),
Needle support (44) and
A puncture ring (45) to which one end of the puncture actuator (49) is fixed, and a puncture ring (45).
Evacuation spring (46) and
Actuator ring (47) and
Including puncture spring (48)
The puncture actuator (49) contracts due to Joule heat generated by energization.
The needle support portion (44) is movable in the injection direction toward the injection site in the puncture ring (45), and the puncture ring (45) is in the injection direction with respect to the retract ring (42). The actuator ring (47) is movable in the injection direction with respect to the puncture ring (45).
During rest , the first blocking means prevents the needle support portion (44) from moving in the injection direction, and the puncture spring (48) that urges the needle support portion (44) in the injection direction. Is held in a compressed state , and the second blocking means prevents the puncture ring (45) from moving in the retracting direction with respect to the retract ring (42), and at the same time, retracts the puncture ring (45). The retracting spring (46) urging in the direction is held in a compressed state .
When the puncture actuator (49) is operated by Joule heat until its contraction reaches 50% of the maximum contraction,
When the actuator ring (47) moves with respect to the puncture ring (45), the obstruction by the first blocking means is released , the puncture spring (48) expands, and the needle support portion (44) Moves in the injection direction, so that the injection needle (40) is inserted into the injection site.
When the puncture actuator (49) is operated by Joule heat until its contraction reaches 100% of the maximum contraction,
When the actuator ring (47) further moves with respect to the puncture ring (45) , the blocking by the second blocking means is released, the retracting spring (46) expands, and the retracting ring (42) On the other hand, the puncture ring (45) and the assembly in which the needle support portion (44) and the injection needle (40) are interconnected move in the retracting direction to move the injection needle (40). An automatic fluid injection device characterized by retracting from the injection site. The automatic fluid injection device according to claim 1, wherein the puncture actuator (49) is a wire, preferably a wire made of a nickel-titanium alloy (Nitinol). The automatic fluid injection device according to claim 2, wherein the wire (49) is transformed into a martensite phase by heating, and its physical dimensions, specifically, a length thereof are changed. The injection mechanism is
Actuator cap (7) containing inflatable material and
A heating means for injecting the fluid from the injection needle (40) into the injection site by heating and inflating the inflatable material and moving the injection piston (6) inside the container (5). (9) The automatic fluid injection device according to any one of claims 1 to 3, wherein the automatic fluid injection device includes. The automatic fluid injection device according to claim 4, wherein the expandable material contains a heat-expandable microsphere. The automatic fluid injection device according to claim 5, wherein the heat-expandable microspheres include hollow thermoplastic microspheres filled with hydrocarbons. The hydrocarbon encapsulated in the thermoplastic microsphere is heated to a temperature range of 60 ° C to 90 ° C, expands and transforms into a gas phase, so that the thermally expandable microsphere has a volume of 5 times the original volume or more. The automatic fluid injection device according to claim 6, wherein the automatic fluid injection device expands 70 times. The automatic fluid injection device according to any one of claims 1 to 7, wherein the support (2) has a sticker for fixing to the injection site. The automatic fluid injection according to any one of claims 1 to 8, wherein the amount of the fluid contained in each of the containers (5) is in the range of 1 mL to 10 mL, preferably about 3 mL. Device. The automatic fluid injection device according to any one of claims 1 to 9, wherein the number of the containers (5) is a plurality, preferably three. The automatic fluid injection device according to any one of claims 1 to 10, further comprising a power supply means, preferably an arbitrary rechargeable battery.

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